The drug development process is typically divided into several phases:
1. Discovery and Preclinical Research: This phase involves the identification of potential drug candidates and extensive laboratory testing. 2. Clinical Trials: These are conducted in three main phases: - Phase I: Tests the drug on a small group of healthy volunteers to assess its safety. - Phase II: Expands the testing to a larger group of people with the target disease to evaluate efficacy and side effects. - Phase III: Involves large-scale testing to confirm efficacy, monitor side effects, and compare the drug to commonly used treatments. 3. Regulatory Review and Approval: The drug is reviewed by regulatory bodies such as the FDA or EMA. If approved, it can be marketed. 4. Post-Marketing Surveillance: Also known as Phase IV, this phase monitors the drug’s long-term effects in the general population.
